safety and efficacy of endobarrier in subjects with type 2 diabetes who are obese

Conditions: Type 2 Diabetes; Obesity

Summary: to determine if the endobarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes

this is a randomized, double blinded, prospective study. subjects will be evaluated and randomized to either the device or sham treatment group if they qualify for the study. a comparison of glycemic control between the two groups will be assessed as the primary outcome measurement as well as the safety profile of the device.

Eligibility criteria:
inclusion criteria: * males/females aged ≥ 21 years and ≤ 65 years * diagnosis of type 2 diabetes for ≤ 20 years * obese individuals (bmi ≥ 30 kg/m2 and ≤ 55 kg/m2) * stable doses (at least 3 months) of up to two anti-t2dm medications (met, su, dpp-4i or tzd) * glycemic state: hba1c at screening ≥ 7.5% and ≤ 10.0%. * subjects willing to comply with study requirements * subjects who have signed an informed consent form exclusion criteria: * diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis * c-peptide \< 1.0 ng/ml * triglyceride level \> 400 mg/dl * vitamin d deficiency (\<20 ng/ml) * male subjects with serum creatinine \>1.5 mg/dl or female subjects with creatinine \>1.4 mg/dl * uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy * height \< 5 feet (152.4 cm) * current alcohol or drug addiction * symptomatic kidney stones or gallstones within 6 months prior to randomization * chronic pancreatitis or acute pancreatitis within 12 months of randomization * diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide * diagnosis of an autoimmune connective tissue disorder (e.g., lupus erythematosus, scleroderma) * active gastroesophageal reflux disease \[gerd\] uncontrolled with a proton pump inhibitor (ppi) * thyroid disease unless controlled with medication * currently taking non-steroidal anti-inflammatory drugs \[nsaids\] (e.g., aspirin, ibuprofen, etc.) within 10 days prior to randomization and/or there is a need or expected use of these agents during the trial 12 months post index procedure * currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 12 months post index procedure * currently taking systemic corticosteroids, drugs known to affect gi motility, prescription/over-the-counter weight loss medications, or medications known to cause significant weight gain or weight loss within 30 days prior to randomization and/or there is a need or expected need to use these medications during the trial 12 months post index procedure * medication for type 2 diabetes other than met, su, dpp-4i, and tzd (e.g., glp1 or insulin) within 3 months of screening * chronic use of narcotics, opiates, benzodiazepines, or other addictive tranquilizers * allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, or any equivalent antibiotics * active helicobacter pylori infection (note: subjects may be eligible after undergoing 2 weeks of antibiotic treatment without re-screening) * previous gi surgery or abnormal gi anatomical finding that could preclude the ability to place the endobarrier device, liner or affect the function of the liner * abnormal pathologies or conditions of the gastrointestinal tract, including current ulcers or crohn's disease, history of atresias or untreated stenoses, current upper gastrointestinal bleeding conditions within 3 months of randomization * any condition or major illness that places the subject at undue risk by participating in the study * poor dentition not allowing complete chewing of food * enrolled in another investigational study within 3 months of screening for this study (enrollment in observational studies is permitted) * residing in a location without ready access to study site medical resources * documented weight loss of \>10 pounds anytime during the 3 months preceding randomization * positive stool guaiac at time of screening

Keywords: glycemic control, type 2 diabetes, device, obese